ID
22988
Beschrijving
Study ID: 100527 Clinical Study ID: B2E100527 Study Title: A randomised, double blind, placebo controlled, parellel group study to examine the efficacy, safety, tolerability and systemic pharmacokinetic profile of repeated inhaled doses of GSK159797 Sponsor: GlaxoSmithKline Phase: phase 2 Study Recruitment Status: Completed Generic Name: milveterol Trade Name: Milveterol Study Indication: Pulmonary Disease, Chronic Obstructive
Trefwoorden
Versies (2)
- 19-06-17 19-06-17 -
- 20-09-21 20-09-21 -
Geüploaded op
19 juni 2017
DOI
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Licentie
Creative Commons BY-NC 3.0
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Main CRF (Treatment Period 3, Day 3-6) - GSK Milveterol COPD 100527
Main CRF (Treatment Period 3, Day 3-6) - GSK Milveterol COPD 100527
Beschrijving
12-Lead Electrocardiogram (Treatment period 3, Day 3-6)
Alias
- UMLS CUI-1
- C0430456
Beschrijving
Sequence number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C0430456
Beschrijving
Date of ECG
Datatype
date
Maateenheden
- dd.mm.yyyy
Alias
- UMLS CUI [1]
- C2826640
Beschrijving
Study day
Datatype
integer
Alias
- UMLS CUI [1]
- C2826182
Beschrijving
Time relative to dosing
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C3469597
- UMLS CUI [1,3]
- C0304229
Beschrijving
Time of ECG
Datatype
time
Maateenheden
- hh:mm
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0013798
Beschrijving
Ventricular rate
Datatype
integer
Maateenheden
- beats/min
Alias
- UMLS CUI [1]
- C2189285
Beschrijving
PR Interval
Datatype
integer
Maateenheden
- msec
Alias
- UMLS CUI [1]
- C0429087
Beschrijving
QRS Duration
Datatype
integer
Maateenheden
- msec
Alias
- UMLS CUI [1]
- C0429025
Beschrijving
QT Interval
Datatype
integer
Maateenheden
- msec
Alias
- UMLS CUI [1]
- C0577807
Beschrijving
QTc Interval
Datatype
integer
Maateenheden
- msec
Alias
- UMLS CUI [1]
- C0855331
Beschrijving
ECG finding
Datatype
integer
Alias
- UMLS CUI [1]
- C0438154
Beschrijving
ECG abnormality clinically significant
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1832603
- UMLS CUI [1,2]
- C2985739
Beschrijving
FEV1 (Treatment Period 3, Day 3-6)
Alias
- UMLS CUI-1
- C0429706
Beschrijving
Sequence number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C0429706
Beschrijving
Date of FEV1
Datatype
date
Maateenheden
- dd.mm.yyyy
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0429706
Beschrijving
Study day
Datatype
integer
Alias
- UMLS CUI [1]
- C2826182
Beschrijving
Time relative to dosing
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C3469597
- UMLS CUI [1,3]
- C0304229
Beschrijving
Time of FEV1 measurement
Datatype
time
Maateenheden
- hh:mm
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0429706
Beschrijving
Reading 1
Datatype
float
Maateenheden
- L
Alias
- UMLS CUI [1,1]
- C0456984
- UMLS CUI [1,2]
- C0429706
Beschrijving
Reading 2
Datatype
float
Maateenheden
- L
Alias
- UMLS CUI [1,1]
- C0456984
- UMLS CUI [1,2]
- C0429706
Beschrijving
Pharmacokinetic sampling (Treatment Period 3, Day 5-6)
Alias
- UMLS CUI-1
- C0201734
Beschrijving
Sequence number pharmacokinetic study
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C0201734
Beschrijving
Date of pharmacokinetic study
Datatype
date
Maateenheden
- dd.mm.yyyy
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0201734
Beschrijving
Study day
Datatype
integer
Alias
- UMLS CUI [1]
- C2826182
Beschrijving
Time relative to dosing
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C3469597
- UMLS CUI [1,3]
- C0304229
Beschrijving
Time of pharmacokinetic study
Datatype
time
Maateenheden
- hh:mm
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0201734
Beschrijving
Sample number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1299222
- UMLS CUI [1,2]
- C0201734
Beschrijving
Blood sample taken
Datatype
boolean
Alias
- UMLS CUI [1]
- C1277698
Beschrijving
Potassium (Treatment Period 3, Day 5-6)
Alias
- UMLS CUI-1
- C0202194
Beschrijving
Sequence number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C2348184
- UMLS CUI [1,2]
- C0202194
Beschrijving
Date of measurement
Datatype
date
Maateenheden
- dd.mm.yyyy
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0202194
Beschrijving
Study day
Datatype
integer
Alias
- UMLS CUI [1]
- C2826182
Beschrijving
Time relative to dosing
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C3469597
- UMLS CUI [1,3]
- C0304229
Beschrijving
Time of measurement
Datatype
time
Maateenheden
- hh:mm
Alias
- UMLS CUI [1,1]
- C0040223
- UMLS CUI [1,2]
- C0202194
- UMLS CUI [2,1]
- C0040223
- UMLS CUI [2,2]
- C0337438
Beschrijving
Test result
Datatype
float
Maateenheden
- mmol/L
Alias
- UMLS CUI [1,1]
- C0587081
- UMLS CUI [1,2]
- C0202194
Beschrijving
Investigational Product (Treatment period 3, Day 3-6)
Alias
- UMLS CUI-1
- C0304229
Beschrijving
Date of dose
Datatype
date
Maateenheden
- dd.mm.yyyy
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
- UMLS CUI [1,3]
- C0011008
Beschrijving
Study day
Datatype
integer
Alias
- UMLS CUI [1]
- C2826182
Beschrijving
Start time of inhalation
Datatype
time
Maateenheden
- hh:mm
Alias
- UMLS CUI [1,1]
- C1301880
- UMLS CUI [1,2]
- C0001559
Beschrijving
End time of inhalation
Datatype
time
Maateenheden
- hh:mm
Alias
- UMLS CUI [1,1]
- C1522314
- UMLS CUI [1,2]
- C0001559
Beschrijving
investigational product change of administration
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C3469597
- UMLS CUI [1,3]
- C0443172
Beschrijving
Specification investigational product change of administration
Datatype
text
Alias
- UMLS CUI [1,1]
- C2348235
- UMLS CUI [1,2]
- C0304229
- UMLS CUI [1,3]
- C3469597
- UMLS CUI [1,4]
- C0443172
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Main CRF (Treatment Period 3, Day 3-6) - GSK Milveterol COPD 100527
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C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0040223 (UMLS CUI [1,2])
C0430456 (UMLS CUI [1,2])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0013798 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
C0429706 (UMLS CUI [1,2])
C0429706 (UMLS CUI [1,2])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0429706 (UMLS CUI [1,2])
C0429706 (UMLS CUI [1,2])
C0429706 (UMLS CUI [1,2])
C0201734 (UMLS CUI [1,2])
C0201734 (UMLS CUI [1,2])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0201734 (UMLS CUI [1,2])
C0201734 (UMLS CUI [1,2])
C0202194 (UMLS CUI [1,2])
C0202194 (UMLS CUI [1,2])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0202194 (UMLS CUI [1,2])
C0040223 (UMLS CUI [2,1])
C0337438 (UMLS CUI [2,2])
C0202194 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0001559 (UMLS CUI [1,2])
C0001559 (UMLS CUI [1,2])
C3469597 (UMLS CUI [1,2])
C0443172 (UMLS CUI [1,3])
C0304229 (UMLS CUI [1,2])
C3469597 (UMLS CUI [1,3])
C0443172 (UMLS CUI [1,4])